1. Field of the Invention
The present invention relates to a device comprising multiple electrodes and multiple leads, particularly pads and leads for use in taking electrocardiograms wherein a plurality of electrical signals in a patient's body are monitored through his or her skin.
2. Background Art
Electrocardiograph (ECG) monitors and recorders are widely used to obtain biopotential signals containing information indicative of the electrical activity associated with the heart and pulmonary system. To obtain biopotential signals, ECG electrodes are applied to the skin of a patient in various locations and coupled to an ECG monitor. Placement of the electrodes is dependent on the information sought by the clinician.
The placement of the ECG electrodes on the patient has been established by medical protocols. The most common protocols require the placement of the electrodes in a 3-lead, a 5-lead or a 12-lead configuration. A 3-lead configuration requires the placement of three electrodes; one electrode adjacent each clavicle bone on the upper chest and a third electrode adjacent the patient's lower left abdomen. A 5-lead configuration requires the placement of the three electrodes in the 3-lead configuration with the addition of a fourth electrode adjacent the sternum and a fifth electrode on the patient's lower right abdomen. A 12-lead configuration requires the placement of 10 electrodes on the patient's body. Four electrodes, which represent the patient's limbs, include the left arm electrode (LA), the right arm electrode (RA), the left leg electrode (LL), and the right leg electrode (RL). Six chest electrodes (V1-V6 leads) are placed on the patient's chest at various locations near the heart. Three additional references are constructed from measurements between the right arm and left arm (Lead I), the right arm and the left leg (Lead II) and the left arm to left leg (Lead III). The ten electrodes provide 12 measurement points consisting of I, II, III, AVR, AVL, AVF, and V1-V6 with the right leg electrode typically used as a ground.
The electrodes, after being positioned on the patient, connect to an ECG monitor by an ECG lead set. The distal end of the ECG lead set, or portion closest to the patient, connects to each electrode (alternatively, the electrodes may be integrated into the distal end of the ECG lead set) and receives biopotential signals from the body. The proximal end of the ECG lead set connects to the ECG input connector and supplies the biopotential signals received from the body to the ECG monitor.
Proper placement of the ECG electrodes and proper connections of the ECG electrodes to the ECG lead sets is critical for obtaining the correct biopotential signals. Clinicians often have difficulty connecting ECG lead sets to ECG electrodes because the individual wires of the ECG lead set often become entangled or because the clinician must determine which individual wire connects to each electrode. In addition, the individual wires of the ECG lead sets are often long and cumbersome resulting in patient discomfort.
Issues with placement of electrodes and connection of the ECG lead set are often compounded during emergency situations. First responders and clinicians often place ECG electrodes on accident victim or heart attack sufferers to establish the medical condition. Any delay may result in adverse consequences. Other emergency treatments may require the rapid removal of ECG electrodes further compounding the issues with entanglement and re-connection.
The present application provides an expandable multiple electrode device having multiple leads and methods of use thereof for preventing the aforementioned problems. Prior art attempts have consistently failed to provide a beneficial and efficient solution to such problems. Such prior art devices include U.S. Pat. No. 3,151,619 to Sullivan that focuses on providing an electrode with a self-contained quantity of electrolyte paste confined within a surrounding band or strip of pressure-sensitive adhesive seal that is adaptable to irregular surfaces.
U.S. Pat. No. 4,233,987 to Feingold comprises electrodes for use in taking electrocardiograms by a multiple electrode pad formed as an elongate, narrow, curved strip with the electrodes arranged in a curvilinear relation to one another. The pad readily assumes the shape of the thorax or chest of a man, woman, or child at several desirable application sites, such as precordially, for routine or emergency use. The strip may be perforated or otherwise weakened in lines between the electrodes for tearing of the strip to separate the electrodes for individualized placement.
U.S. Pat. No. 6,205,346 to Akiva comprises an electrode apron for ECG which is comprised of an apron cast from flexible material to be placed over the chest of the patient, ten electrodes inlaid within the apron in predetermined places wherein six of the said electrodes are located at predetermined distances between the ribs, two under each shoulder and two at both sides of the stomach. Either curved or spiraled conductors are cast within flexible material and each conductor is connected to an electrode. A multiple-pronged cable feeds each of the conductors and includes a connector for connecting the apron to any standard ECG measuring device. The apron also has straps and a belt for tightening the apron on the body of the patient, locating the electrodes of the apron in their required locations for ECG tests.
U.S. Pat. No. 6,847,836 to Sujdak comprises an ECG electrode chest pad particularly adapted for use in emergency room situations having upper fit portions with upper limb electrodes, and elongated central or medial base fit portion with a plurality of precordal unipolar electrodes and lower fit portions with lower limb electrodes, said electrodes being attached to leads which are internal to the base chest pad and terminate into at least one lead branch adapted to plug into an ECG monitor and having a perforation in the base pad material such that one group of electrodes may be separated from a second group of electrodes to facilitate ease of patient monitoring and complimentary medical procedures.
U.S. Pat. Pub. No. 2008/0177168 to Callahan et al. comprises an ECG lead set including an ECG electrode assembly and a lead set hub. The ECG electrode includes at least one electrode configured to receive biopotential signals from a patient, a plug connector for connecting said ECG electrode assembly, a web, connected between the at least one electrode and the plug connector and configured to form an electrical connection therebetween. The lead set hub includes at least one receptacle configured to receive the plug connector of the ECG electrode assembly.
Electrodes of the prior art are typically provided in the form of standard fixed strips. However, a standard fixed strip of electrodes does not fit all patients due to variations in patient size, gender, weight, and other physical factors. The devices of the prior art do not allow for movement of the electrodes to allow for proper placement on different people having varying chest sizes; do not allow for exact placement of all the electrodes; and do not allow for electrodes to be separated or placed as a one-piece unit. The devices of the prior art also do not allow for a female person to remain wearing her undergarments while applying the electrode pad; and furthermore the devices of the prior art do not allow for “V4R” (V4R is a position on the body that is mid-clavicular over the fifth intercostal space and the R represents the patient's right side) to be obtained with the same electrode. These prior art fixed strips of electrodes must be sized to the patient and do not allow for movement to lengthen the distance between electrodes as is provided for by the present invention.
Herein is described a device that allows for the electrodes to be stretched farther apart or pressed closer together as needed allowing the device to fit virtually all patients except for potentially the very small. This electrode pad comprises electrodes on a flexible and stretchy material allowing for speedy and accurate placement. This electrode strip can be stretched apart or pressed closer together for an accurate fit for children and adult patients of a wide range of sizes. The present invention provides a multitude of benefits including but not limited to faster performance of 12 lead electrocardiograph, facilitating application and decreasing application time, increasing wire management by reducing/eliminating tangles, improving readings due to less artifacts, increasing adhesion due to larger application area, improving female patient modesty by application around worn garments, facilitating evaluation of V4A (right side heart attack), providing a relatively low cost of manufacture for addition of significant functional benefits, providing a one-size-fits-all stretchable device allowing for both speed and accuracy in use, and the like.